Drug recall
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System…
FDA recall event 33854 · Class II · Advanced Sterilization Products
Key facts
| Event ID | 33854 |
|---|---|
| Recall numbers | Z-2100-2012 |
| Recalling firm | Advanced Sterilization Products |
| Product type | Devices |
| Products | STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of… |
| Initiation date | Jun 28, 2012 |
| Report date | Aug 8, 2012 |
| Termination date | Aug 13, 2013 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3003662624 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: